Medicinal Products

ABASAGLAR 100 units / ml

Generic drug of the therapeutic class: Metabolism and nutrition
Active ingredients: Insulin glargine
laboratory: Lilly France Sas

Injectable solution
in pre-filled pen box of 5 pre-filled pens of 3 ml
All forms

Indication

Treatment of diabetes mellitus in adults, adolescents and children from 2 years.

Dosage ABASAGLAR 100 units / ml solution for injection in a pre-filled pen box of 5 pre-filled pens of 3 ml

Treatment of diabetes mellitus in adults, adolescents and children from 2 years.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Adverse effects Abasaglar

Summary of the security profile

Hypoglycaemia, usually the most common side effect of any insulin therapy, may occur if the insulin dose is higher than needed.

Table listing the side effects

Adverse reactions reported in clinical studies are listed below, according to the MedDRA classification, by organ system classes and in descending order of occurrence frequencies (very common: ≥ 1/10, frequent: ≥ 1 / 100, <1/10, uncommon: ≥ 1/1000, <1/100, rare: ≥ 1/10 000, <1/1000, very rare: <1/10 000).

Within each frequency group, adverse effects are presented in descending order of severity.

Classes of MedDRA Organ Systems

Very common

Frequent

Rare

Rare

Very rare

Immune system disorders

Allergic reactions

X

Metabolism and nutrition disorders

hypoglycemia

X

Nervous system disorders

dysgeusia

X

Eye disorders

Altered vision

X

retinopathy

X

Skin and subcutaneous tissue disorders

lipohypertrophy

X

lipoatrophy

X

Musculoskeletal and systemic disorders

myalgia

X

General disorders and administration site conditions

Feedback to the site

injection

X

Edema

X

Description of the above-mentioned adverse effects

Metabolism and nutrition disorders

Episodes of severe hypoglycemia, especially if repeated, can lead to neurological damage. Episodes of prolonged or severe hypoglycaemia may be life-threatening. In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of a compensatory adrenergic reaction. In general, the faster and faster the fall in blood glucose, the more marked the adrenoreactive reaction and its symptoms.

Immune system disorders

Immediate hypersensitivity reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or its excipients may be accompanied by, for example, generalized skin reactions, angioedema, bronchospasm, hypotension, and a shock, and may be life threatening.

Insulin administration may cause the formation of insulin antibodies. In clinical studies, the frequency of cross-reactive antibodies to human insulin and insulin glargine was similar in the NPH insulin and insulin glargine groups.

In rare cases, the presence of these insulin antibodies may make it necessary to adjust the insulin dose to correct a tendency to hyper- or hypoglycemia.

Eye disorders

A marked change in glycemic equilibrium may result in transient impairment of vision due to temporary alteration of the turgor and refractive index of the lens.

Improved long-term glycemic control decreases the risk of progression of diabetic retinopathy. However, an intensification of insulin therapy inducing a sudden improvement in glycemic equilibrium may cause a transient aggravation of diabetic retinopathy. Severe hypoglycaemia may cause transient amaurosis in patients with proliferative retinopathy, particularly if it has not been treated with photocoagulation.

Skin and subcutaneous tissue disorders

As with any insulin therapy, lipodystrophy may occur at the injection site, which may delay local resorption of insulin. Continuous rotation of the injection sites in a given area may help to decrease or avoid these reactions.

General disorders and administration site conditions

Administration site reactions include redness, pain, pruritus, urticaria, swelling or inflammation. Most minor insulin reactions at the injection site usually disappear within a few days to a few weeks.

In rare cases, insulin can cause sodium retention and edema, especially if the previously poor metabolic balance is improved by intensive insulin therapy.

Pediatric population

In general, the safety profile is identical in children and adolescents (≤ 18 years) and in adults. Adverse reaction reports received during postmarketing surveillance showed a relatively higher frequency of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash)., urticaria) in children and adolescents (≤ 18 years) than in adults. In children less than 2 years old, there are no safety data from clinical studies.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

Popular Posts

Category Medicinal Products, Next Article